MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-05-12 for DIMENSION VISTA? DIMENSION VISTA? 500 SMN 10284473 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[75040825]
The cause for the discordant low igg result is unknown. Siemens is investigating the incident.
Patient Sequence No: 1, Text Type: N, H10
[75040826]
A discordant low immunoglobulin g (igg) result was obtained on a patient sample on the dimension vista 500 system. The patient result was reported to the physician. The same sample was repeated on the same instrument and a higher result was obtained. A corrected result was issued. There are no known reports of patient intervention or adverse health consequences due to the discordant low igg result.
Patient Sequence No: 1, Text Type: D, B5
[86893412]
The original mdr 2517506-2017-00490 was filed 5-12-2017. The cause for the discordant low igg result is unknown. Siemens headquarters support center concluded their investigation of the incident. The analysis revealed that a general product or instrument system issue could be excluded. In order to exclude a performance issue of the igg flex reagent cartridge lot 17016ma involved, the performance of this lot was tested using a retained sample. All calibration curves were valid and all controls were found within their assigned range. The investigations showed that the assay performed as specified. The analysis revealed that the customer did not follow the corresponding ifu as the sample was not centrifuged for 10 min at approximately 15 000 x g prior to testing. The dimension vista igg instructions for use states: "turbidity and particles in the samples may interfere with the determination. Therefore, samples containing particles must be centrifuged prior to testing. Lipemic or turbid samples, which cannot be clarified by centrifugation (10 minutes at approximately 15,000 x g), must not be used. " the device is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2017-00490 |
| MDR Report Key | 6563498 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-12 |
| Date of Report | 2017-06-12 |
| Date of Event | 2017-04-14 |
| Date Mfgr Received | 2017-05-19 |
| Device Manufacturer Date | 2013-09-19 |
| Date Added to Maude | 2017-05-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD |
| Manufacturer Street | REGISTRATION NUMBER 1226181 101 SILVERMINE ROAD |
| Manufacturer City | BROOKFIELD CT 06804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA? |
| Generic Name | DIMENSION VISTA? 500 SYSTEM |
| Product Code | CFQ |
| Date Received | 2017-05-12 |
| Model Number | DIMENSION VISTA? 500 |
| Catalog Number | SMN 10284473 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Brand Name | DIMENSION VISTA? |
| Generic Name | DIMENSION VISTA? 500 SYSTEM |
| Product Code | JJE |
| Date Received | 2017-05-12 |
| Model Number | DIMENSION VISTA? 500 |
| Catalog Number | SMN 10284473 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-12 |